Open clinical study of antihypertensive efficacy of generic drug telmisartan (hypotel) or a combination with S-amlodipine (Semlopin) or hydrochlorothiazide in the therapy of patients with mild to moderate arterial hypertension (ah) (results of the hipster

Abstract

The aim of the study was to evaluate the antihypertensive effect of a generic drug telmisartan (Hypotel manufactured by Kusum Pharm, Ukraine) in monotherapy or in combination with S-amlodipine (Semlopin manufactured by Kusum Pharm, Ukraine) in patients with mild to moderate arterial hypertension. Materials and methods. The study included 40 patients with mild to moderate hypertension. After a seven-day wash-out period, all patients underwent initial examination and distribution into the groups by sealed-envelope method, depending on the prescribed antihypertensive therapy. At the end of the withdrawal period, criteria for inclusion in the study were evaluated again. If patients met inclusion criteria and had no exclusion criteria, they were randomized. Hypotel has been administered at a dose of 40–80 mg once daily for 2 weeks. In failure to reach target blood pressure less than 140/90 mmHg, Semlopin 2.5–5 mg once a day was added for 1 more month. If target blood pressure was not achieved, hydrochlorothiazide 12.5 mg once daily was added. Duration of follow-up was 6 months. Results. The average age of patients was 55.85 ± 2.09 years. The average weight was 87.30 ± 2.77 kg. Average body mass index — 29.41 ± 0.63 kg/m2. Average office systolic (SBP) and diastolic blood pressure (DBP) at baseline were 155.88 ± 1.63 mmHg and 92.60 ± 1.43 mmHg, respectively. The average heart rate (HR) — 71.40 ± 1.29 bpm. Mean blood pressure du­ring ambulatory monitoring was 139.37 ± 1.49 mmHg for SBP, 82.47 ± 1.84 mmHg — for DBP. Average daily HR — 71.38 ± 1.32 bpm. Against the background of Hypotel therapy, a reduction of office blood pressure in the whole group at the stages of 14 days, 4, 8 and 24 weeks was –14.0/7.7; –22.0/10.7; –25.5/13.5; –26.8/12.3 mmHg, respectively (p < 0.05) for all values. Lowering blood pressure during daily monitoring in patients receiving Hypotel, after 24 weeks of treatment was 15.7/9.3 mmHg for the entire period, for the day period — 15.3/9.2 mmHg, for the night period — 15.4/8.7 mmHg (p < 0.05) for all values. Reaching the target blood pressure during the office monitoring was 80 % for the whole group; in Hypotel monotherapy, 100 % of patients achieved the target blood pressure, in the combination therapy with Hypotel plus Semlopin — 72 % of patients. During the daily monito­ring, achievement of target BP in the whole group was 90 %, with Hypotel monotherapy — 93 %, and in combination of Hypotel with Semlopin — 80 %. The incidence of adverse reactions was 2.5 %. Conclusions. Telmisartan in monotherapy or in combination with S-amlodipine effectively lowers blood pressure during both the office measurement, and the daily monitoring for 24 weeks of treatment in patients with mild to moderate arterial hypertension.

Mancia G., De Backer G., Dominiczak A. et al. 2007 Guidelines for the Management of arterial hypertension. The task force for the management of arterial hypertension of the European Society of Hypertension and of the European Society of Cardio­logy // J. Hypertension. — 2007. — Vol. 25. — P. 1105-1187.